Social Media And Risk-reduction Training for Infant Care Practices (SMART) (SMART)

• ClinicalTrials.gov Identifier: NCT01713868
• Recruitment Status: Completed
• First Posted: October 25, 2012
• Results First Posted: January 3, 2019
• Last Update Posted: January 11, 2019
• Sponsor: University of Virginia
• Collaborators: Yale University; Boston University
• Information provided by (Responsible Party): Rachel Moon, MD, University of Virginia

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Single (Participant); Primary Purpose: Prevention
• Condition: Risk Reduction
• Interventions: Behavioral: Safe Sleep Nursery Education; Behavioral: Breastfeeding Nursery Education; Behavioral: Breastfeeding Mobile Health Messaging; Behavioral: Safe Sleep Mobile Health Messaging
• Enrollment: 1600

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Safe Sleep Edu and Breastfeeding mHealth	Breastfeeding Edu and Safe Sleep mHealth	Safe Sleep Edu and Safe Sleep mHealth	Breastfeed Edu and Breastfeed mHealth
Arm/Group Description	Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.	Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.	Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.	Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
Period Title: Overall Study
Started	400	400	400	400
Completed	303	335	320	305
Not Completed	97	65	80	95

Baseline Characteristics

Arm/Group Title		Safe Sleep Edu and Breastfeeding mHealth	Breastfeeding Edu and Safe Sleep mHealth	Safe Sleep Edu and Safe Sleep mHealth	Breastfeed Edu and Breastfeed mHealth	Total
Arm/Group Description		Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.	Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.	Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.	Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.	Total of all reporting groups
Overall Number of Baseline Participants		400	400	400	400	1600
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	400 participants	400 participants	400 participants	400 participants	1600 participants
	<=18 years	32 8.0%	14 3.5%	42 10.5%	21 5.3%	109 6.8%
	Between 18 and 65 years	368 92.0%	386 96.5%	358 89.5%	379 94.8%	1491 93.2%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	400 participants	400 participants	400 participants	400 participants	1600 participants
		27.0 (5.9)	29.3 (5.8)	27.1 (5.9)	27.6 (5.7)	27.9 (5.6)
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	303 participants	335 participants	320 participants	305 participants	1263 participants
	Female	303 100.0%	335 100.0%	320 100.0%	305 100.0%	1263 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
		[1] Measure Analysis Population Description: Number of participants with data to analyze differed from the number of participants recruited because of attrition.
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	400 participants	400 participants	400 participants	400 participants	1600 participants
	Hispanic or Latino	128 32.0%	121 30.3%	144 36.0%	127 31.8%	520 32.5%
	Not Hispanic or Latino	272 68.0%	279 69.8%	256 64.0%	273 68.3%	1080 67.5%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	400 participants	400 participants	400 participants	400 participants	1600 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	12 3.0%	26 6.5%	6 1.5%	20 5.0%	64 4.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	173 43.3%	101 25.3%	95 23.8%	133 33.3%	502 31.4%
	White	112 28.0%	205 51.2%	187 46.8%	141 35.3%	645 40.3%
	More than one race	20 5.0%	11 2.8%	7 1.8%	8 2.0%	46 2.9%
	Unknown or Not Reported	83 20.8%	57 14.2%	105 26.3%	98 24.5%	343 21.4%
Maternal educational level [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	303 participants	335 participants	320 participants	305 participants	1263 participants
	Less than high school	36 11.9%	11 3.3%	31 9.7%	10 3.3%	88 7.0%
	High school or GED	84 27.7%	63 18.8%	77 24.1%	88 28.9%	312 24.7%
	Some college	102 33.7%	114 34.0%	118 36.9%	104 34.1%	438 34.7%
	College or more	80 26.4%	147 43.9%	92 28.7%	101 33.1%	420 33.3%
	Unknown	1 0.3%	0 0.0%	2 0.6%	2 0.7%	5 0.4%
		[1] Measure Analysis Population Description: Because of attrition, number analyzed is less than number recruited.
Household income [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	303 participants	335 participants	320 participants	305 participants	1263 participants
	Less than $20,000	49 16.2%	30 9.0%	55 17.2%	47 15.4%	181 14.3%
	$20,000-49.999	59 19.5%	62 18.5%	56 17.5%	62 20.3%	239 18.9%
	$50,000 or more	81 26.7%	175 52.2%	91 28.4%	88 28.9%	435 34.4%
	Unknown	114 37.6%	68 20.3%	118 36.9%	108 35.4%	408 32.3%
		[1] Measure Analysis Population Description: Because of attrition, number analyzed is less than number recruited
Maternal marital status [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	303 participants	335 participants	320 participants	305 participants	1263 participants
	Married	127 41.9%	203 60.6%	147 45.9%	163 53.4%	640 50.7%
	Never married	158 52.1%	111 33.1%	151 47.2%	132 43.3%	552 43.7%
	Divorced, separated, or widowed	14 4.6%	20 6.0%	14 4.4%	8 2.6%	56 4.4%
	Unknown	4 1.3%	1 0.3%	8 2.5%	2 0.7%	15 1.2%
		[1] Measure Analysis Population Description: Because of attrition, number analyzed is less than number recruited

Outcome Measures

1. Primary Outcome

Title	Adherence With Recommended Supine Sleep Position
Description	Hypothesis:For supine sleep position, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Results analyzed at 2+ months infant age.

Arm/Group Title	Safe Sleep Edu and Breastfeeding mHealth	Breastfeeding Edu and Safe Sleep mHealth	Safe Sleep Edu and Safe Sleep mHealth	Breastfeed Edu and Breastfeed mHealth
Arm/Group Description:	Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.	Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.	Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.	Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
Overall Number of Participants Analyzed	301	333	319	303
Measure Type: Count of Participants; Unit of Measure: Participants
Usual supine sleep position	230 76.4%	294 88.3%	294 92.2%	243 80.2%
Usual nonsupine position	71 23.6%	39 11.7%	25 7.8%	60 19.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Safe Sleep Edu and Breastfeeding mHealth, Breastfeeding Edu and Safe Sleep mHealth, Safe Sleep Edu and Safe Sleep mHealth, Breastfeed Edu and Breastfeed mHealth
	Comments	Sample size provided power of detecting the effect of an individual intervention in the presence of interaction.We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.
	Type of Statistical Test	Superiority
	Comments	GEE logistic regression accounted for within-hospital clustering, individual-level & hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was significant, we presented results from the interaction model.
Statistical Test of Hypothesis	P-Value	0.03
	Comments	Adjusted education effect p=0.34. Adjusted mHealth effect p<0.001. Test for interaction p=0.01. Adjusted education only effect p=0.74. Adjusted mHealth only effect p=0.02. Adjusted mHealth and education effect: p=0.03
	Method	Regression, Logistic
	Comments	[Not Specified]

2. Primary Outcome

Title	Adherence With Recommended Roomsharing Without Bed Sharing
Description	Hypothesis: For roomsharing without bed sharing, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Safe Sleep Edu and Breastfeeding mHealth	Breastfeeding Edu and Safe Sleep mHealth	Safe Sleep Edu and Safe Sleep mHealth	Breastfeed Edu and Breastfeed mHealth
Arm/Group Description:	Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.	Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.	Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.	Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
Overall Number of Participants Analyzed	293	328	313	291
Measure Type: Count of Participants; Unit of Measure: Participants
Roomsharing without bedsharing	218 74.4%	262 79.9%	269 85.9%	205 70.4%
Not roomsharing without bedsharing	75 25.6%	66 20.1%	44 14.1%	86 29.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Safe Sleep Edu and Breastfeeding mHealth, Breastfeeding Edu and Safe Sleep mHealth, Safe Sleep Edu and Safe Sleep mHealth, Breastfeed Edu and Breastfeed mHealth
	Comments	Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p<0.05). Allowing for 20% loss to follow-up,this led to a sample of n=1600.
	Type of Statistical Test	Superiority
	Comments	GEE logistic regression accounted for within-hospital clustering, individual-level & hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Adjusted education effect: p=0.22. Adjusted mHealth effect p<0.001. Test for interaction p=0.08.
	Method	Regression, Logistic
	Comments	[Not Specified]

3. Primary Outcome

Title	Adherence With Recommended Pacifier Use
Description	Hypothesis: For pacifier use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Safe Sleep Edu and Breastfeeding mHealth	Breastfeeding Edu and Safe Sleep mHealth	Safe Sleep Edu and Safe Sleep mHealth	Breastfeed Edu and Breastfeed mHealth
Arm/Group Description:	Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.	Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.	Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.	Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
Overall Number of Participants Analyzed	290	326	315	291
Measure Type: Count of Participants; Unit of Measure: Participants
Usual pacifier use	193 66.6%	226 69.3%	240 76.2%	174 59.8%
Usual no pacifier use	97 33.4%	100 30.7%	75 23.8%	117 40.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Safe Sleep Edu and Breastfeeding mHealth, Breastfeeding Edu and Safe Sleep mHealth, Safe Sleep Edu and Safe Sleep mHealth, Breastfeed Edu and Breastfeed mHealth
	Comments	Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.
	Type of Statistical Test	Superiority
	Comments	GEE logistic regression accounted for within-hospital clustering, individual-level & hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Adjusted education effect p=0.07. Adjusted mHealth effect p<0.001. Test for interaction p=0.54
	Method	Regression, Logistic
	Comments	[Not Specified]

4. Primary Outcome

Title	Adherence With Recommended Avoiding Use of Soft Bedding
Description	Hypothesis: For each recommended avoidance of soft bedding use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Safe Sleep Edu and Breastfeeding mHealth	Breastfeeding Edu and Safe Sleep mHealth	Safe Sleep Edu and Safe Sleep mHealth	Breastfeed Edu and Breastfeed mHealth
Arm/Group Description:	Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.	Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.	Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.	Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
Overall Number of Participants Analyzed	300	333	320	299
Measure Type: Count of Participants; Unit of Measure: Participants
No soft bedding use	204 68.0%	259 77.8%	262 81.9%	202 67.6%
Soft bedding use	96 32.0%	74 22.2%	58 18.1%	97 32.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Safe Sleep Edu and Breastfeeding mHealth, Breastfeeding Edu and Safe Sleep mHealth, Safe Sleep Edu and Safe Sleep mHealth, Breastfeed Edu and Breastfeed mHealth
	Comments	Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.
	Type of Statistical Test	Superiority
	Comments	GEE logistic regression accounted for within-hospital clustering, individual-level & hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Adjusted education effect p=0.33. Adjusted mHealth effect p<0.001. Test for interaction p=0.29.
	Method	Regression, Logistic
	Comments	[Not Specified]

5. Secondary Outcome

Title	Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep
Description	Questions assessing attitudes toward sleep position included the mothers' ratings regarding if she believed that each infant sleep position (back, side, stomach) made the baby healthy, safer, more comfortable, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both supine and side sleep would lead to a categorization of not having positive attitudes towards supine sleep only).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.

Arm/Group Title	Control	mHealth Safe Sleep
Arm/Group Description:	Received mHealth breastfeeding	Received mHealth safe sleep
Overall Number of Participants Analyzed	608	655
Measure Type: Count of Participants; Unit of Measure: Participants
# reporting positive attitudes re supine sleep	313 51.5%	491 75.0%
# reporting nonpositive attitudes re supine sleep	295 48.5%	164 25.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, mHealth Safe Sleep
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	Causal mediation analysis
Method of Estimation	Estimation Parameter	Difference in proportions
	Estimated Value	0.16
	Estimation Comments	[Not Specified]
Other Statistical Analysis		We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.

6. Secondary Outcome

Title	Number of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.
Description	Questions assessing attitudes toward sleep location (bedsharing, roomsharing without bedsharing) assessed whether the location was pleasant for the baby and/or mother, safer for the baby, more comfortable for the baby and/or mother, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both bedsharing and not bedsharing would lead to a categorization of not having positive attitudes towards bedsharing only).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.

Arm/Group Title	Control	mHealth Safe Sleep
Arm/Group Description:	Received mHealth breastfeeding	Received mHealth safe sleep
Overall Number of Participants Analyzed	608	655
Measure Type: Count of Participants; Unit of Measure: Participants
Positive attitude re: roomsharing w/o bedsharing	306 50.3%	442 67.5%
Nonpositive attitude re roomsharing w/o bedsharing	302 49.7%	213 32.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, mHealth Safe Sleep
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	Causal mediation analysis
Method of Estimation	Estimation Parameter	Difference in proportions
	Estimated Value	0.14
	Estimation Comments	[Not Specified]
Other Statistical Analysis		We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.

7. Secondary Outcome

Title	Number of Participants Reporting Positive/Nonpositive Social Norms re Supine Sleep
Description	Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep

Arm/Group Title	Control	mHealth Safe Sleep
Arm/Group Description:	Received mHealth breastfeeding	Received mHealth safe sleep
Overall Number of Participants Analyzed	608	655
Measure Type: Count of Participants; Unit of Measure: Participants
Positive social norms re supine sleep	332 54.6%	466 71.1%
Nonpositive social norms re supine sleep	276 45.4%	189 28.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, mHealth Safe Sleep
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	Causal mediation analysis
Method of Estimation	Estimation Parameter	Difference in proportions
	Estimated Value	0.14
	Estimation Comments	[Not Specified]
Other Statistical Analysis		We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.

8. Secondary Outcome

Title	Number of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.
Description	Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.

Arm/Group Title	Control	mHealth Safe Sleep
Arm/Group Description:	Received mHealth breastfeeding	Received mHealth safe sleep
Overall Number of Participants Analyzed	608	655
Measure Type: Count of Participants; Unit of Measure: Participants
Positive social norms re roomsharing w/o bedsharin	297 48.8%	350 53.4%
Nonpositive norms re roomsharing w/o bedsharing	311 51.2%	305 46.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, mHealth Safe Sleep
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	Causal mediation analysis
Method of Estimation	Estimation Parameter	Difference in proportions
	Estimated Value	0.15
	Estimation Comments	[Not Specified]
Other Statistical Analysis		We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.

Adverse Events

Time Frame	24 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Safe Sleep Edu and Breastfeeding mHealth	Breastfeeding Edu and Safe Sleep mHealth	Safe Sleep Edu and Safe Sleep mHealth	Breastfeed Edu and Breastfeed mHealth
Arm/Group Description	Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.	Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.	Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging Safe Sleep Nursery Education: Nursery-based program for safe sleep Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.	Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
All-Cause Mortality
	Safe Sleep Edu and Breastfeeding mHealth	Breastfeeding Edu and Safe Sleep mHealth	Safe Sleep Edu and Safe Sleep mHealth	Breastfeed Edu and Breastfeed mHealth
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/400 (0.00%)	0/400 (0.00%)	0/400 (0.00%)	0/400 (0.00%)
Serious Adverse Events
	Safe Sleep Edu and Breastfeeding mHealth	Breastfeeding Edu and Safe Sleep mHealth	Safe Sleep Edu and Safe Sleep mHealth	Breastfeed Edu and Breastfeed mHealth
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/400 (0.00%)	0/400 (0.00%)	0/400 (0.00%)	0/400 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Safe Sleep Edu and Breastfeeding mHealth	Breastfeeding Edu and Safe Sleep mHealth	Safe Sleep Edu and Safe Sleep mHealth	Breastfeed Edu and Breastfeed mHealth
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/400 (0.00%)	0/400 (0.00%)	0/400 (0.00%)	0/400 (0.00%)

Limitations and Caveats

There was a 21% loss to follow-up, not generalizable to non-English-speaking populations, not powered to assess adverse events, did not measure clinical outcomes (i.e., rates of sudden unexpected infant death), and the results were self-reported

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Michael Corwin, MD
• Organization: Boston University
• EMail: mjcorwin@bu.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Moon RY, Corwin MJ, Kerr S, Heeren T, Colson E, Kellams A, Geller NL, Drake E, Tanabe K, Hauck FR. Mediators of Improved Adherence to Infant Safe Sleep Using a Mobile Health Intervention. Pediatrics. 2019 May;143(5). pii: e20182799. doi: 10.1542/peds.2018-2799.

Moon RY, Hauck FR, Colson ER, Kellams AL, Geller NL, Heeren T, Kerr SM, Drake EE, Tanabe K, McClain M, Corwin MJ. The Effect of Nursing Quality Improvement and Mobile Health Interventions on Infant Sleep Practices: A Randomized Clinical Trial. JAMA. 2017 Jul 25;318(4):351-359. doi: 10.1001/jama.2017.8982.

• Responsible Party: Rachel Moon, MD, University of Virginia
• ClinicalTrials.gov Identifier: NCT01713868
• Other Study ID Numbers: 1R01HD072815-01 ( U.S. NIH Grant/Contract )
• First Submitted: October 19, 2012
• First Posted: October 25, 2012
• Results First Submitted: November 14, 2018
• Results First Posted: January 3, 2019
• Last Update Posted: January 11, 2019